US_Regulatory Affairs Manager I_CO

About the job

Key Responsibilities

• Lead and coordinate global regulatory submissions and product registration dossiers for complex products and programs.
• Develop and manage regulatory submission and registration plans across multiple international markets.
• Support regulatory approvals and maintain product licenses throughout the product lifecycle, including regulatory change controls.
• Develop and implement regulatory strategies based on changing requirements across the US, Europe, China, and other global markets.
• Interpret regulatory requirements and translate them into practical strategies for product development and commercialization.
• Address and resolve complex regulatory and health authority issues with limited guidance.
• Partner with Quality, R&D, Clinical, Manufacturing, Product Development, and other cross-functional stakeholders.
• Manage relationships with health authorities, notified bodies, external partners, and other regulatory organizations.
• Support preparation for regulatory audits and health authority interactions.